Problem Reporting

Medical Devices

• Recall Reporting for Medical Devices:
  • Medical device initial recall reporting form (FRM-0360)
  • Medical device final recall reporting form (FRM-0360)
• Guide to Recalls of Medical Devices (GUI-0054)
• Guidance on Investigation of Reported Medical Device Problems (GUI-0065)
• Mandatory Problem Reporting for Medical Devices
  • Preliminary Report Form (FRM-0237)
  • Final Report Form (FRM-0238)
  • Preliminary and Final Report Form (FRM-0255)
• Consultation: Draft Documents for Medical Devices Program

If you want to report an adverse reaction or a problem about another type of product, please visit Health Canada's Adverse Reaction Reporting web page.